Leiomyoma MedDRA version: 17.1 Level: LLT Classification code 10046784 Term: Uterine fibroids System Organ Class: 100000004864 MedDRA version: 17.1 Level: LLT Classification code 10016628 Term: Fibroids System Organ Class: 100000004864 MedDRA version: 17.1 Level: LLT Classification code 10022794 Term: Intramural leiomyoma of uterus System Organ Class: 100000004864
Conditions
Interventions
Product Name: BAY 1002670 coated tablet 2 mg 245
Product Code: BAY 1002670
Pharmaceutical Form: Coated tablet
INN or Proposed INN: vilaprisan
Current Sponsor code: BAY 1002670
Other descriptive name:
Sponsors
Bayer HealthCare AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed and dated informed consent 2. Women, 18 to 50 years of age at the time of screening 3. Diagnosis of uterine fibroid(s) documented by transvaginal or abdominal ultrasound at screening with at least 1 fibroid with largest diameter >/=3.0 cm 4. Heavy menstrual bleeding (HMB) >80 mL documented by menstrual pictogram (MP) in a bleeding episode during the screening period Women who did not suffer from perceived HMB during the 3 months prior to Visit 1 due to any effective medical treatment, e.g. with a hormonal contraceptive, are not considered appropriate candidates and should not undergo further screening procedures. Women suffering from perceived HMB despite medical treatment, e.g. with a hormonal contraceptive, are appropriate candidates for further screening, if rules on stopping prior medication are followed. 5. Eligible to undergo surgical treatment for uterine fibroids at the end of study treatment 6. Good general health (except for findings related to uterine fibroids) as proven by medical history, physical and gynecological examinations, and laboratory test results 7. Normal or clinically insignificant cervical smear not requiring further follow-up. Human papilloma virus (HPV) testing in subjects with atypical squamous cells of undetermined significance (ASCUS) can be used as an adjunctive test. Subjects with ASCUS can be included if they are negative for high-risk HPV strains. 8. An endometrial biopsy performed during the screening period, without significant histological disorder such as endometrial hyperplasia (including simple hyperplasia) or other significant endometrial pathology. 9. Use of an acceptable nonhormonal method of contraception (i.e. either male condom, cap, diaphragm or sponge, each in combination with spermicide) starting at the bleeding episode following the screening visit 1 (Visit 1) until the end of the study. This is not required if safe contraception is achieved by a permanent method, such as bilateral fallopian tube blockage of the subject or vasectomy of the partner(s). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 138 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before start of treatment) 2. Uterine fibroid with largest diameter >10.0 cm 3. Hypersensitivity to any ingredient of the study drugs 4. Hemoglobin values </= 6 g/dL or any condition requiring immediate blood transfusion (subjects with hemoglobin values </=10.9 g/dL will be offered iron supplementation). 5. Women with bleeding/spotting episodes lasting longer than 10 days should not be included. 6. Any diseases or conditions that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug 7. Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results 8. Abuse of alcohol, drugs, or medicines (e.g. laxatives) 9. Use of other treatments that might interfere with the conduct of the study or the interpretation of the results 10. Undiagnosed abnormal genital bleeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of vilaprisan in subjects with uterine fibroids compared to placebo.;Secondary Objective: To assess the efficacy of vilaprisan in subjects with uterine fibroids compared to ulipristal. To evaluate the safety of vilaprisan in subjects with uterine fibroids. ;Primary end point(s): Amenorrhea (yes/no) Defined as no scheduled or unscheduled bleeding/spotting after end of the initial bleeding episode until the end of the respective treatment period;Timepoint(s) of evaluation of this end point: After end of the intial bleeding until treatment day 84 of each treatment period | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Number of bleeding days 2. Time to onset of controlled bleeding 3. Percent change in volume of largest fibroid compared to baseline 4. Endometrial histology (classical histology) 5. Endometrial thickness;Timepoint(s) of evaluation of this end point: 1. From start of treatment until the day before the next treatment period would start again 2. From baseline until end of treatment 3. From baseline until end of treatment 4. From baseline until end of follow-up period 5. From baseline until end of follow-up period | — |
Countries
Austria, Belgium, Czech Republic, Finland, Germany, Hungary, Lithuania, Netherlands, Poland, Portugal, Spain, Sweden, United Kingdom
Contacts
Public ContactBayer Clinical Trial Contact
Bayer HealthCare AG
Outcome results
None listed